(27 days)
The CLS™ Spotorno™ Femoral Stem is intended for cementless use in total hip replacement in treatment of the following:
- patient conditions of noninflammatory degenerative joint disease (NIDJD), e.g. avascular necrosis, osteoarthritis and conditions of inflammatory degenerative joint disease (IJD), e.g. rheumatoid arthritis;
- those patients with failed previous surgery where pain, deformity, or dysfunction persists;
- revision of previously failed hip arthroplasty.
The CLS™ Spotorno™ Femoral Stem is intended for use as a prosthetic replacement of the proximal portion of the femur during total hip arthroplasty. This Special 510(k) incorporates the following changes as compared to the original device configuration: 1) addition of the CLS 125° stem, with an increased offset; and 2) incorporation of a slim neck and short taper. Below the resection line, the design of the modified stem remains the same as the legally marketed device.
The provided text describes a medical device submission, specifically a Special 510(k) for a modified femoral stem (CLS™ Spotorno™ Stem). The core of the provided information relates to the fatigue testing of this device to ensure it continues to meet safety and effectiveness standards after modifications.
Here's an analysis of the acceptance criteria and study as per your request:
Acceptance Criteria and Study Details for the CLS™ Spotorno™ Femoral Stem
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Survive physiological loading (fatigue testing) | All test samples met the acceptance criteria, thus indicating that the device, as modified, will survive physiological loading. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document states "All test samples" but does not specify the exact number of samples used for fatigue testing.
- Data Provenance: The study was conducted by the manufacturer, Zimmer Austin, Inc. and Zimmer GmbH. The data is prospective, generated specifically for this 510(k) submission to demonstrate the safety and effectiveness of the modified device. The country of origin for the testing would be where Zimmer GmbH (Switzerland) or Zimmer Austin, Inc. (USA) conducted the tests, which is not explicitly stated but implied to be within the manufacturer's quality system.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This study involves mechanical fatigue testing, not a clinical study where expert ground truth on patient data would be established. The "ground truth" here is the physical performance of the device under simulated physiological loading conditions as defined by engineering standards for orthopedic implants.
4. Adjudication Method for the Test Set
Not applicable. As noted above, this is mechanical testing, not a clinical study requiring expert adjudication of observations. The "adjudication" is based on whether the test samples pass or fail the predetermined engineering acceptance criteria.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. This is a submission for a medical device (femoral stem) based on mechanical testing (fatigue testing), not an AI-enabled diagnostic or imaging device. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant or applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, in a sense. The "standalone" performance here refers to the physical device itself (the femoral stem) undergoing mechanical testing without human interaction or an AI algorithm involved in its function or assessment during the test. The "algorithm" would be the engineering specifications and test protocols that determine acceptance.
7. The Type of Ground Truth Used
The ground truth used is derived from engineering standards and predetermined mechanical performance criteria for orthopedic implants, specifically for fatigue strength under physiological loading. These standards are typically established by regulatory bodies (e.g., ISO, ASTM) and industry best practices to ensure the long-term durability and safety of the implant.
8. The Sample Size for the Training Set
Not applicable. There is no AI algorithm being "trained" in this context. The study is a mechanical verification of a physical device.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there's no AI training set, there's no ground truth for it to be established.
§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.
(a)
Identification. A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.(b)
Classification. Class II.